Pediatric Trauma Centers RE-AIM at Gun Safety

NCT ID: NCT06123611

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-25
• Study Completion Date: 2027-09-30

Brief Summary

Universal firearm injury and violence prevention counseling of parents and patients has been recommended by multiple national organizations for over a decade, yet clinicians rarely deliver this counseling. Barriers to its implementation must be addressed in order to effectively deliver firearm related injury prevention efforts. This study will implement a universal firearm injury prevention initiative within a national cohort of three pediatric trauma centers. The investigator's long-term goal is to demonstrate best practices for pediatric trauma center-based firearm injury prevention strategies that promote safe storage practices and reduce firearm related injury and death. This research will test the effectiveness of a comprehensive training strategy for improving the implementation of a universal firearm injury prevention effort, ACTFAST (Adopting Comprehensive Training for FireArm Safety in Trauma centers), to 1) increase the adoption, implementation and sustainability of a universal firearm injury prevention initiative within participating pediatric level 1 trauma centers; 2) increase firearm safety knowledge, attitudes and safe firearm storage practices among parents of pediatric trauma patients and youth patients treated within participating pediatric level 1 trauma centers, and 3) increase trauma center clinicians' firearm safety knowledge and confidence in delivering a firearm safety intervention.

Conditions

Firearm Injury; Safety Issues

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard Care

In the pre-implementation period, all trauma patients will receive standard routine care. Which may include some screening and counseling on gun safety.

Group Type: NO_INTERVENTION

No interventions assigned to this group

ACTFAST Intervention

During the implementation and maintenance periods, all trauma patients will receive study activities including firearm access screening, counseling on safe storage practices, and referral to safe storage and other community resources as appropriate.

Group Type: EXPERIMENTAL

Adopting Comprehensive Training for FireArm Safety in Trauma centers

Intervention Type: BEHAVIORAL

Firearm access screening, brief firearm safe storage intervention, and referral to community and preventive health resources

Interventions

Adopting Comprehensive Training for FireArm Safety in Trauma centers

Firearm access screening, brief firearm safe storage intervention, and referral to community and preventive health resources

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• live with an admitted pediatric trauma patient at a participating trauma center
• be fluent in English or Spanish

• Must be between the ages of 11-17 years
• admitted to a participating trauma inpatient service for an injury
• fluent in English or Spanish
• able to provide written assent and parent able to provide written consent

Exclusion Criteria

• family members who do not live with the admitted pediatric trauma patient

For youth trauma patients:

• Youth who are prisoners or in police custody
• Youth who are admitted due to suicide attempt
• Youth with acute conditions that would preclude provision of informed consent (i.e., acute psychosis, altered mental status, cognitive impairment)

• Minimum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Children's Hospitals and Clinics of Minnesota

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: collaborator

Rhode Island Hospital

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine Hoops, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Johns Hopkins Medicine

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

CE003620

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00407213

Identifier Type: -

Identifier Source: org_study_id